{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T05:05:41Z","timestamp":1761541541372},"reference-count":18,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2020,6,21]],"date-time":"2020-06-21T00:00:00Z","timestamp":1592697600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>In patients with coronary heart disease undergoing primary prevention, hypertriglyceridemia is a residual risk for cardiovascular events. Omega\u20103 carboxylic acid (OM3\u2010CA), a mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), may be beneficial in reducing triglyceride levels. As part of the clinical development program of OM3\u2010CA in China, this phase I study evaluated the pharmacokinetics, safety, and tolerability profile of OM3\u2010CA in healthy subjects. The pharmacokinetic results of this study were also compared with those of available data for Western populations. Fourteen healthy Chinese subjects (aged 18\u201045 years) received once\u2010daily oral OM3\u2010CA 4 g for 14\u00a0consecutive days. Pharmacokinetic parameters were assessed from both baseline\u2010uncorrected and baseline\u2010corrected plasma concentrations vs time profile of EPA, DHA, and EPA plus DHA. Following single and multiple oral doses of OM3\u2010CA, the absorption of EPA, DHA, and EPA plus DHA was steady with median t<jats:sub>max<\/jats:sub> occurring at 5.5\u20136 hours after both single and multiple dosing. Close to steady\u2010state concentrations in plasma were reached after 14 days of continuous once\u2010daily dosing, and accumulation was confirmed for EPA, DHA, and EPA plus DHA. Of the 14 subjects treated with OM3\u2010CA, 6 (42.9%) reported at least 1 adverse event (diarrhea) during the study, which was determined as mild and treatment emergent. No serious adverse events were reported. In summary, the pharmacokinetic profile of oral OM3\u2010CA 4 g after single and multiple dosing in healthy Chinese subjects is consistent with that observed in other ethnic populations.<\/jats:p>","DOI":"10.1002\/cpdd.800","type":"journal-article","created":{"date-parts":[[2020,6,22]],"date-time":"2020-06-22T04:07:06Z","timestamp":1592798826000},"page":"985-994","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Pharmacokinetics of Single and Multiple Doses of Omega\u20103 Carboxylic Acids in Healthy Chinese Subjects: A Phase I, Open\u2010Label Study"],"prefix":"10.1002","volume":"9","author":[{"given":"Shan","family":"Jing","sequence":"first","affiliation":[{"name":"Clinical Pharmacology Centre Beijing Anzhen Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhenxian","family":"Zhang","sequence":"additional","affiliation":[{"name":"R&amp;D China AstraZeneca  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaowen","family":"Chen","sequence":"additional","affiliation":[{"name":"R&amp;D China AstraZeneca  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rui","family":"Miao","sequence":"additional","affiliation":[{"name":"R&amp;D China AstraZeneca  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catarina","family":"Nilsson","sequence":"additional","affiliation":[{"name":"Quantitative Clinical Pharmacology Early Clinical Development AstraZeneca Research and Development  Gothenburg Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yang","family":"Lin","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Centre Beijing Anzhen Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,6,21]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"Centers for Disease Control and Prevention. Heart disease facts.https:\/\/www.cdc.gov\/heartdisease\/facts.htm. Published November 2017. Accessed August 20 2019."},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCOUTCOMES.115.002104"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13537"},{"key":"e_1_2_11_5_1","first-page":"108","article-title":"Expert consensus on hypertriglyceridemia and its cardiovascular risk management","volume":"45","author":"China Cholesterol Education Planning Committee","year":"2017","journal-title":"Chin J Cardiol"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1812792"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.atherosclerosis.2008.06.003"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)60527-3"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000709"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacl.2013.10.003"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacl.2012.01.002"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.2147\/VHRM.S50464"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/clc.23055"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.360"},{"key":"e_1_2_11_15_1","unstructured":"European Medicines Agency. 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